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OBJECTIVE: This work responds to the limited research about resilience when living with dementia and develops a conceptual model to inform service development and healthcare practices for this population. METHODS: An iterative process of theory building across four phases of activity (scoping review n = 9 studies), stakeholder engagement (n = 7), interviews (n = 11) generated a combined sample of 87 people living with dementia and their carers, including those affected by rare dementias to explore their lived experiences. An existing framework of resilience developed in other populations served as the starting point to analyse and synthesise the findings, inspiring a new conceptual model of resilience unique to the experience of living with dementia. RESULTS: The synthesis suggests resilience encompasses the daily struggles of living with a dementia; people are not flourishing, thriving or 'bouncing back', but are managing and adapting under pressure and stress. The conceptual model suggests resilience may be achieved through the collective and collaborative role of psychological strengths, practical approaches to adapting to life with dementia, continuing with hobbies, interests and activities, strong relationships with family and friends, peer support and education, participating in community activities and support from healthcare professionals. Most of these themes are not reflected in resilience outcome measures. CONCLUSIONS: Practitioners adopting a strengths-based approach utilising the conceptual model at the point of diagnosis and post-diagnosis support may help individuals achieve resilience through appropriately tailored services and support. This 'resilience practice' could also extend to other degenerative or debilitating chronic conditions a person faces in their life course.
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Cuidadores , Demencia , Humanos , Cuidadores/psicología , Personal de Salud , Acontecimientos que Cambian la Vida , Evaluación de Resultado en la Atención de SaludRESUMEN
Psychometrically sound resilience outcome measures are essential to establish how health and care services or interventions can enhance the resilience of people living with dementia (PLWD) and their carers. This paper systematically reviews the literature to identify studies that administered a resilience measurement scale with PLWD and/or their carers and examines the psychometric properties of these measures. Electronic abstract databases and the internet were searched, and an international network contacted to identify peer-reviewed journal articles. Two authors independently extracted data. They critically reviewed the measurement properties from the available psychometric data in the studies, using a standardised checklist adapted for purpose. Fifty-one studies were included in the final review, which applied nine different resilience measures, eight developed in other populations and one developed for dementia carers in Thailand. None of the measures were developed for use with people living with dementia. The majority of studies (N = 47) focussed on dementia carers, three studies focussed on people living with dementia and one study measured both carers and the person with dementia. All the studies had missing information regarding the psychometric properties of the measures as applied in these two populations. Nineteen studies presented internal consistency data, suggesting seven of the nine measures demonstrate acceptable reliability in these new populations. There was some evidence of construct validity, and twenty-eight studies hypothesised effects a priori (associations with other outcome measure/demographic data/differences in scores between relevant groups) which were partially supported. The other studies were either exploratory or did not specify hypotheses. This limited evidence does not necessarily mean the resilience measure is not suitable, and we encourage future users of resilience measures in these populations to report information to advance knowledge and inform further reviews. All the measures require further psychometric evaluation in both these populations. The conceptual adequacy of the measures as applied in these new populations was questionable. Further research to understand the experience of resilience for people living with dementia and carers could establish the extent current measures -which tend to measure personal strengths -are relevant and comprehensive, or whether further work is required to establish a new resilience outcome measure.
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Cuidadores , Demencia , Humanos , Psicometría , Reproducibilidad de los Resultados , Evaluación de Resultado en la Atención de SaludRESUMEN
BACKGROUND: Many people living with dementia remain undiagnosed, with diagnosis usually occurring long after signs and symptoms are present. A timely diagnosis is important for the wellbeing of the person living with dementia and the family, allowing them to plan and have access to support services sooner. The aim of this study was to identify demographic characteristics and neuropsychiatric symptoms associated with being undiagnosed, which may help clinicians be more aware of signs that could be indicative of early-stage or undetected dementia. METHODS: This cross-sectional study uses data from waves 1 and 2 (two years apart) of the Cognitive Function and Ageing Studies Wales (CFAS Wales). CFAS Wales participants were included who had a study assessment of dementia, as determined by the Automated Geriatric Examination for Computer Assisted Taxonomy (AGECAT) algorithm and by expert assessment, and who had had their primary care records checked for a clinical diagnosis of dementia. We identified 19 people with a diagnosis of dementia and 105 people living with undiagnosed dementia, and explored demographic characteristics and the presence or absence of a range of neuropsychiatric symptoms in the undiagnosed population using logistic regression. RESULTS: Findings suggest that people living with dementia who have better cognition, have more years of education, or live in more deprived areas are less likely to have a diagnosis. In terms of neuropsychiatric symptoms, depression and sleep problems were associated with being undiagnosed. Apathy was common across all people living with dementia, but those with a diagnosis were more likely to have severe apathy. CONCLUSIONS: This study has clinical practice implications as the findings may help clinicians be more aware of characteristics and symptoms of people who are undiagnosed or who are at greater risk of remaining undiagnosed, enabling them to be more vigilant in picking up signs of dementia at an earlier stage.
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Demencia , Anciano , Envejecimiento , Cognición , Estudios Transversales , Demencia/diagnóstico , Demencia/epidemiología , Demencia/psicología , Humanos , Gales/epidemiologíaRESUMEN
This paper proposes the design of a bipedal robotic controller where the function between the sensory input and motor output is treated as a black box derived from human data. In order to achieve this, we investigated the causal relationship between ground contact information from the feet and leg muscle activity n human walking and calculated filter functions which transform sensory signals to motor actions. A minimal, nonlinear, and robust control system was created and subsequently analysed by applying it to our bipedal robot RunBot III without any central pattern generators or precise trajectory control. The results demonstrate that our controller can generate stable robotic walking. This indicates that complex locomotion patterns can result from a simple model based on reflexes and supports the premise that human-derived control strategies have potential applications in robotics or assistive devices.
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Pie/inervación , Locomoción/fisiología , Modelos Biológicos , Músculo Esquelético/fisiología , Robótica/instrumentación , Adulto , Fenómenos Biomecánicos , Simulación por Computador , Electromiografía , Retroalimentación Sensorial , Femenino , Humanos , Masculino , Adulto JovenRESUMEN
Background: legislation places an onus on local authorities to be aware of care needs in their locality and to prevent and reduce care and support needs. The existing literature overlooks ostensibly 'healthy' and/or non-users of specific services, non-health services and informal assistance and therefore inadequately explains what happens before or instead of individuals seeking services. We sought to address these gaps by exploring older adults' accounts of seeking assistance in later life. Methods: we conducted semi-structured qualitative interviews with 40 adults aged 68-95. We invited participants to discuss any type of support, intervention, or service provision, whether medical, social, family-provided, paid or unpaid. Findings: this paper reports older people's accounts of how they evaluated their need for assistance. We found that the people in our sample engaged in a recursive process, evaluating their needs on an issue-by-issue basis. Participants' progression through this process hinged on four factors: their acknowledgement of decline; the perceived impact of decline on their usual activities and independence; their preparedness to be a recipient of assistance; and, the opportunity to assert their need. In lieu of seeking assistance, participants engaged in self-management, but also received unsolicited or emergency assistance. Conclusions: older people's adaptations to change and attempts to meet their needs without assistance mean that they do not present to services, limiting the local authority's knowledge of their needs and ability to plan appropriate services. Our findings offer four stages for policymakers, service providers and carers to target to address the uptake of assistance.
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Envejecimiento/psicología , Conocimientos, Actitudes y Práctica en Salud , Aceptación de la Atención de Salud , Autocuidado/psicología , Adaptación Psicológica , Factores de Edad , Anciano , Anciano de 80 o más Años , Costo de Enfermedad , Femenino , Humanos , Vida Independiente , Entrevistas como Asunto , Masculino , Investigación Cualitativa , Reino UnidoRESUMEN
BACKGROUND: Potentially modifiable lifestyle factors may influence cognitive health in later life and offer potential to reduce the risk of cognitive decline and dementia. The concept of cognitive reserve has been proposed as a mechanism to explain individual differences in rates of cognitive decline, but its potential role as a mediating pathway has seldom been explored using data from large epidemiological studies. We explored the mediating effect of cognitive reserve on the cross-sectional association between lifestyle factors and cognitive function in later life using data from a population-based cohort of healthy older people. METHODS AND FINDINGS: We analysed data from 2,315 cognitively healthy participants aged 65 y and over in the Cognitive Function and Ageing Study Wales (CFAS-Wales) cohort collected in 2011-2013. Linear regression modelling was used to investigate the overall associations between five lifestyle factors-cognitive and social activity, physical activity, diet, alcohol consumption, and smoking-and cognition, adjusting for demographic factors and chronic conditions. Mediation analysis tested for indirect effects of the lifestyle factors on cognition via cognitive reserve. After controlling for age, gender, and the presence of chronic conditions, cognitive and social activity, physical activity, healthy diet, and light-to-moderate alcohol consumption were positively associated with cognitive function, together accounting for 20% (95% CI 17%-23%) of variance in cognitive test scores. Cognitive reserve was an important mediator of this association, with indirect effects via cognitive reserve contributing 21% (95% CI 15%-27%) of the overall effect on cognition. The main limitations of the study derive from the cross-sectional nature of the data and the challenges of accurately measuring the latent construct of cognitive reserve. CONCLUSIONS: Cross-sectional associations support the view that enhancing cognitive reserve may benefit cognition, and maintenance of cognitive health may be supported by a healthy and active lifestyle, in later life.
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Cognición , Reserva Cognitiva , Estilo de Vida , Anciano , Anciano de 80 o más Años , Estudios Transversales , Escolaridad , Femenino , Humanos , Masculino , Ocupaciones , GalesRESUMEN
National dementia strategies are government policies that guide the provision of appropriate support for people living with dementia. These strategies, developed through extensive stakeholder engagement, should be tailored to the cultural and demographic needs of a country. Using a mixed methods survey design, this study explored the aims of the Dementia Action Plan (2018-2022) for Wales (UK) around assessment, diagnosis, and post-diagnostic support, and assessed whether these are being realized. Further, it sought to gain insight from people living with dementia and their carers around how the experience may be improved for others in the future, as the development of the next iteration of the Action Plan is anticipated. Respondents included 71 people, affected by typical and rarer types of dementia, living in both rural and urban areas. Findings suggest both positive and negative experiences, reflecting a 'postcode lottery' of service provision. Attainable recommendations for improvement were made by respondents, which would ultimately likely be cost-effective and reduce strain on formal services. The findings reported in this paper concur with those reported by people living with dementia in other countries, indicating their relevance for policymakers beyond Wales.
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Demencia , Humanos , Demencia/diagnóstico , Gales , Anciano , Masculino , Femenino , Anciano de 80 o más Años , Persona de Mediana Edad , Encuestas y Cuestionarios , Cuidadores/psicologíaRESUMEN
OBJECTIVES: Aberrant movement-related cortical activity has been linked to impaired motor function in Parkinson's disease (PD). Dopaminergic drug treatment can restore these, but dosages and long-term treatment are limited by adverse side-effects. Effective non-pharmacological treatments could help reduce reliance on drugs. This experiment reports the first study of home-based electroencephalographic (EEG) neurofeedback training as a non-pharmacological candidate treatment for PD. Our primary aim was to test the feasibility of our EEG neurofeedback intervention in a home setting. METHODS: Sixteen people with PD received six home visits comprising symptomology self-reports, a standardised motor assessment, and a precision handgrip force production task while EEG was recorded (visits 1, 2 and 6); and 3 × 1-hr EEG neurofeedback training sessions to supress the EEG mu rhythm before initiating handgrip movements (visits 3 to 5). RESULTS: Participants successfully learned to self-regulate mu activity, and this appeared to expedite the initiation of precision movements (i.e., time to reach target handgrip force off-medication pre-intervention = 628 ms, off-medication post-intervention = 564 ms). There was no evidence of wider symptomology reduction (e.g., Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III Motor Examination, off-medication pre-intervention = 29.00, off-medication post intervention = 30.07). Interviews indicated that the intervention was well-received. CONCLUSION: Based on the significant effect of neurofeedback on movement-related cortical activity, positive qualitative reports from participants, and a suggestive benefit to movement initiation, we conclude that home-based neurofeedback for people with PD is a feasible and promising non-pharmacological treatment that warrants further research.
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BACKGROUND AND OBJECTIVES: Policies to support people living with dementia increasingly focus on strengths-based approaches, highlighting the importance of building resilience. This research responds to the lack of a suitable resilience measure for people with dementia. It develops a pool of items to inform a new measure of resilience for this population. METHODS: A conceptual model and associated data informed the item generation of the draft resilience measure. Regular meetings with professionals (n = 7) discussed response-scale formatting, content and face validity, leading to refinement and item reduction. Cognitive interviews with people living with dementia (n = 11) then examined the face and content validity of items and the suitability of response-scale formatting. These two phases informed subsequent revision and further item reduction of the resilience measure. RESULTS: The first item generation exercise led to 140 items. These were independently assessed by the professionals and this refinement reduced the measure to 63 items across 7 domains of the conceptual model (psychological strengths; practical approaches for adapting to life with dementia; continuing with hobbies, interests and activities; strong relationships with family and friends; peer support and education; participating in community activities; the role of professional support services). Cognitive interviews explored the 63 items with people living with dementia. Detailed feedback led to items removed due to difficulty with (a) understanding (N = 7); (b) answering (n = 11); (c) low preference for that item (n = 6); and (d) presence of a preferred item within a cluster of similar questions (n = 4). Items were amended to enhance clarity/conciseness (n = 19) leading to a final 37-item pool. CONCLUSION: Established methods for measurement development included the expertise of people with dementia and led to the generation of a set of items for a new resilience measure that were understandable and acceptable to this target population. This 37-item pool reflects the conceptual understanding of resilience in dementia as being derived across individual, community and societal level resources.
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Demencia , Medición de Resultados Informados por el Paciente , Humanos , Reproducibilidad de los Resultados , Calidad de Vida/psicología , Demencia/psicologíaRESUMEN
There is widespread concern about the potential impact on health and social care services of the ageing population and long-term health conditions, such as dementia. To effectively plan services it is important to understand current need and use and identify gaps in provision. Using data from the Cognitive Function and Ageing Study Wales (CFAS Wales), we used logistic regression to model the relationship between health (self-rated health, cognitive impairment, and activities of daily living), and the use of health and care services. CFAS Wales is a longitudinal cohort study of people aged 65 years and over, in two areas in Wales, UK, over-sampling those aged 75 years and over. Participants (n = 3593) answered a wide range of health and lifestyle questions and completed a variety of cognitive and physical health assessments. Data from 3153 people from wave 1 and 1968 people from wave 2 were analysed. As anticipated we found poorer health, on some indicators, predicted greater service use, including social care, hospital, general practitioner, and nursing services. However, cognitive impairment did not predict greater service use, except for social care. Controlling for age, sex, socio-economic status, social connection indices and area environment, conversely we found lower reported uptake of allied health services by people with cognitive impairment. Further analysis showed that people with a cognitive impairment were less likely to report having a sight-check or seeing a dentist in the previous year, a finding replicated in wave 2. These differences were not explained by transportation issues. In contrast, we did not find a significant difference in reported uptake of hearing checks or physiotherapist use, with mixed evidence of differences in chiropodist visits. Not accessing these preventative services may not only exacerbate existing conditions but have further downstream negative consequences for health and well-being in people who are cognitively impaired.
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Background: Co-morbidity is a major late-life challenge with poor outcomes, yet many older people are resilient. We consider an ecopsychosocial framework of resilience to investigate this disparity. This theorises that sources of resilience may be personal, social and structural. We explored older people's responses and reactions to significant life experiences, to understand resilience development for managing later life health challenges. Methods: We applied a two-stage, cross-sectional mixed-methods design to the Cognitive Function and Ageing Studies Wales (CFAS Wales). Participants' defined quantitatively as resilient (high level of well-being despite co-morbidity) were identified in the wave 1 dataset. A sub-sample of the resilient participants aged 65+ were randomly selected for semi-structured interviews (N = 20). Qualitative thematic analyses were both inductive and deductive. Results: The analyses revealed four primary life experiences reflecting different developmental trajectories. "Early years as formative" and "work and employment as formative" occurred at normative developmental stages in the life-course. In contrast non-normative life events such as loss, bereavement, illness of self, and others underpinned the themes of "adverse events and experiences" and "caring experiences." Four potential mechanisms for resilience were central to these life experiences, reflecting reactions, actions, and development: "character and self-identity;" "approach to life and insight;" "meaningful relationships and belonging." Conclusions: This work contributes further theoretical insights into the ecopsychosocial resilience framework. It highlights the process of interdependence between the individual and the wider environment, suggesting how the availability and accessibility of resources and human agency (protective factors), can influence, and be influenced by, the timing of significant events and experiences. In doing so, it corroborates international healthy ageing policy which recognises resilience as important for a public health response to support older people to adjust to changes and losses experienced in later life. It highlights the importance of current and future policies and services for supporting the management of adverse events earlier in the life-course, and recommends that policies and services take a "long view" on population health and well-being and consider the whole life-course, in addition to specific points in the ageing process.
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A success story within neuroimaging has been the discovery of distinct neural correlates of episodic retrieval, providing insight into the processes that support memory for past life events. Here we focus on one commonly reported neural correlate, the left parietal old/new effect, a positive going modulation seen in event-related potential (ERP) data that is widely considered to index episodic recollection. Substantial evidence links changes in the size of the left parietal effect to changes in remembering, but the precise functional utility of the effect remains unclear. Here, using forced choice recognition of verbal stimuli, we present a novel population level test of the hypothesis that the magnitude of the left parietal effect correlates with memory performance. We recorded ERPs during old/new recognition, source accuracy and Remember/Know/Guess tasks in two large samples of healthy young adults, and successfully replicated existing within participant modulations of the magnitude of the left parietal effect with recollection. Critically, however, both datasets also show that across participants the magnitude of the left parietal effect does not correlate with behavioral measures of memory - including both subjective and objective estimates of recollection. We conclude that in these tasks, and across this healthy young adult population, the generators of the left parietal ERP effect do not index performance as expected. Taken together, these novel findings provide important constraints on the functional interpretation of the left parietal effect, suggesting that between group differences in the magnitude of old/new effects cannot always safely be used to infer differences in recollection.
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This study presents an innovative multichannel functional electrical stimulation gait-assist system which employs a well-established purely reflexive control algorithm, previously tested in a series of bipedal walking robots. In these robots, ground contact information was used to activate motors in the legs, generating a gait cycle similar to that of humans. Rather than developing a sophisticated closed-loop functional electrical stimulation control strategy for stepping, we have instead utilised our simple reflexive model where muscle activation is induced through transfer functions which translate sensory signals, predominantly ground contact information, into motor actions. The functionality of the functional electrical stimulation system was tested by analysis of the gait function of seven healthy volunteers during functional electrical stimulation-assisted treadmill walking compared to unassisted walking. The results demonstrated that the system was successful in synchronising muscle activation throughout the gait cycle and was able to promote functional hip and ankle movements. Overall, the study demonstrates the potential of human-inspired robotic systems in the design of assistive devices for bipedal walking.
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Estimulación Eléctrica , Reflejo , Caminata/fisiología , Adulto , Algoritmos , Fenómenos Biomecánicos , Femenino , Marcha , Humanos , MasculinoRESUMEN
BACKGROUND: Social exclusion of the elderly is a key policy focus but evidence on the processes linking health and social exclusion is hampered by the variety of ways that health is used in social exclusion research. We investigated longitudinal associations between health and social exclusion using an analytical framework that did not conflate them. METHODS: Data employed in this study came from 4 waves of Understanding Society, the UK Household Longitudinal Study 2009-2013. The sample comprised all adults who took part in all 4 waves, were 65â years or more in Wave 3, and had complete data on our variables of interest for each analysis. We used linear regression to model the relationship between Wave 2/3 social exclusion and Wave1-2 health transitions (N=4312) and logistic regression to model the relationship between Wave2/3 social exclusion and Wave 4 health states, conditional on Wave 3 health (N=4244). RESULTS: There was a dose-response relationship between poor health in Waves 1 and 2 and later social exclusion. Use of a car, mobile phone and the internet moderated the association between poor health and social exclusion. Given the health status in Wave 3, those who were more socially excluded had poorer outcomes on each of the three domains of health in Wave 4. CONCLUSIONS: Use of the internet and technology protected older adults in poor health from social exclusion. Age-friendly hardware and software design might have public health benefits.
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Estado de Salud , Aislamiento Social , Anciano , Ergonomía , Femenino , Humanos , Internet/estadística & datos numéricos , Estudios Longitudinales , Masculino , Diseño de Software , Reino UnidoRESUMEN
Everyday functioning relies on episodic memory, the conscious retrieval of past experiences, but this crucial cognitive ability declines severely with aging and disease. Vulnerability to memory decline varies across individuals however, producing differences in the time course and severity of memory problems that complicate attempts at diagnosis and treatment. Here we identify a key source of variability, by examining gene dependent changes in the neural basis of episodic remembering in healthy adults, targeting seven polymorphisms previously linked to memory. Scalp recorded Event-Related Potentials (ERPs) were measured while participants remembered words, using an item recognition task that requires discrimination between studied and unstudied stimuli. Significant differences were found as a consequence of a Single Nucleotide Polymorphism (SNP) in just one of the tested genes, PRKCA (rs8074995). Participants with the common G/G variant exhibited left parietal old/new effects, which are typically seen in word recognition studies, reflecting recollection-based remembering. During the same stage of memory retrieval participants carrying a rarer A variant exhibited an atypical pattern of brain activity, a topographically dissociable frontally-distributed old/new effect, even though behavioural performance did not differ between groups. Results replicated in a second independent sample of participants. These findings demonstrate that the PRKCA genotype is important in determining how episodic memories are retrieved, opening a new route towards understanding individual differences in memory.
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Memoria Episódica , Recuerdo Mental/fisiología , Polimorfismo de Nucleótido Simple/genética , Proteína Quinasa C-alfa/genética , Proteína Quinasa C-alfa/fisiología , Análisis de Varianza , Discriminación en Psicología/fisiología , Potenciales Evocados/fisiología , HumanosRESUMEN
Control of human walking is not thoroughly understood, which has implications in developing suitable strategies for the retraining of a functional gait following neurological injuries such as spinal cord injury (SCI). Bipedal robots allow us to investigate simple elements of the complex nervous system to quantify their contribution to motor control. RunBot is a bipedal robot which operates through reflexes without using central pattern generators or trajectory planning algorithms. Ground contact information from the feet is used to activate motors in the legs, generating a gait cycle visually similar to that of humans. Rather than developing a more complicated biologically realistic neural system to control the robot's stepping, we have instead further simplified our model by measuring the correlation between heel contact and leg muscle activity (EMG) in human subjects during walking and from this data created filter functions transferring the sensory data into motor actions. Adaptive filtering was used to identify the unknown transfer functions which translate the contact information into muscle activation signals. Our results show a causal relationship between ground contact information from the heel and EMG, which allows us to create a minimal, linear, analogue control system for controlling walking. The derived transfer functions were applied to RunBot II as a proof of concept. The gait cycle produced was stable and controlled, which is a positive indication that the transfer functions have potential for use in the control of assistive devices for the retraining of an efficient and effective gait with potential applications in SCI rehabilitation.
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Marcha , Reflejo , Robótica/instrumentación , Caminata , Algoritmos , Humanos , Análisis y Desempeño de TareasRESUMEN
BACKGROUND: Performing gait analysis in a clinical setting can often be challenging due to time, cost and the availability of sophisticated three-dimensional (3D) gait analysis systems. This study has developed and tested a portable wireless gait assessment tool (wi-GAT) to address these challenges. AIM: To investigate the concurrent validity of the wi-GAT in measuring spatio-temporal gait parameters such as stride length, stride duration, cadence, double support time (DST), stance and swing time compared to a 3D Vicon motion analysis system. METHODS: Ten healthy volunteers participated in the study (age range 23-30 years). Spatio-temporal gait parameters were recorded simultaneously by the Vicon and the wi-GAT systems as each subject walked at their self-selected speed. RESULTS: The stride length and duration, cadence, stance duration and walking speed recorded using the wi-GAT showed strong agreement with those same parameters recorded by the Vicon (ICC of 0.94-0.996). A difference between the systems in registering "toe off" resulted in less agreement (ICC of 0.299-0.847) in gait parameters such as %stance and %swing and DST. DISCUSSION AND CONCLUSION: The study demonstrated good concurrent validity for the wi-GAT system. The wi-GAT has the potential to be a useful assessment tool for clinicians.
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Marcha , Rehabilitación/instrumentación , Tecnología Inalámbrica , Adulto , Fenómenos Biomecánicos , Femenino , Humanos , Masculino , Factores de Tiempo , Caminata , Tecnología Inalámbrica/economía , Adulto JovenRESUMEN
Histaminergic neurons are regulators of the sleep-wake cycle. We evaluated the alerting effects of MK-7288 (10, 20 mg), a novel histamine-3 receptor inverse agonist (H3RIA), along with modafinil (200 mg), a standard treatment, in a randomized, double-blind, placebo controlled, crossover study of 56 patients with excessive daytime sleepiness (EDS). Efficacy was assessed using maintenance of wakefulness tests (MWT) and car driving simulation tests. MK-7288 and modafinil significantly prolonged MWT sleep latency (improvements vs. placebo of 8.1 to 8.2 min for MK-7288 and 10.2 min for modafinil), and improved car driving simulation standard deviation of lane position (reduction vs. placebo of -0.1 m for each treatment). MK-7288 was associated with more insomnia (29%) than modafinil (9%) and placebo (6%). The study demonstrated the potential of the H3RIA mechanism for treating EDS, but did not show efficacy differentiation from modafinil. Early-stage comparative effectiveness can help prevent late-stage failure and increase the cost-effectiveness of drug development.